| Primary | Mean Percent Change From Baseline in Body Weight | Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable body weight data. | Posted | | Least Squares Mean | Standard Error | Percent change | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-14.4± 0.98
- OG001-19.9± 1.01
- OG002-2.4± 1.00
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed Models Analysis | | <0.001 | | LS Mean Difference | -12.0 | | | 2-Sided | 95 | -14.8 | -9.3 | | | | | Superiority | | | | | Mixed Models Analysis | | <0.001 |
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| Primary | Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis. | All participants who received at least one dose of study drug and had evaluable body weight data. | Posted | | Number | | Percentage of participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Body Weight | Mean Change from Baseline in Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable body weight data. | Posted | | Least Squares Mean | Standard Error | kilograms (kg) | | Baseline, Week 20 | | | | ID | Title | Description |
|---|
| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis. | All participants who received at least one dose of study drug and had evaluable body weight data. | Posted | | Number | | Percentage of participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis. | All participants who received at least one dose of study drug and evaluable body weight data. | Posted | | Number | | Percentage of participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Waist Circumference | Mean Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable waist circumference data. | Posted | | Least Squares Mean | Standard Error | centimeters (cm) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Absolute Body Weight | Mean Change from Baseline in Absolute Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable body weight data. | Posted | | Least Squares Mean | Standard Error | kilograms (kg) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Body Mass Index (BMI) | Mean Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable BMI data. | Posted | | Least Squares Mean | Standard Error | kilograms per metres squared (kg/m^2) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Hemoglobin A1c (HbA1c) | Mean Change from Baseline in HbA1c. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | all participants who received at least one dose of study drug and had evaluable HbA1c data. | Posted | | Least Squares Mean | Standard Error | Percentage of HbA1c | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Fasting Glucose (FSG) | Mean Change from Baseline in FSG. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable fasting glucose data. | Posted | | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable SF-36v2 data. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. |
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| Secondary | Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable IWQOL-Lite-CT data. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | | OG002 |
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| Secondary | Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model with Variable = Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable blood pressure data. | Posted | | Least Squares Mean | Standard Error | millimeters of Mercury (mmHg) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable blood pressure data. | Posted | | Least Squares Mean | Standard Error | millimeters of Mercury (mmHg) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model using log (Actual measurement/Baseline) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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| Secondary | Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg) | LS mean was determined using MMRM model with log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of study drug and had evaluable fasting insulin data. | Posted | | Least Squares Mean | Standard Error | milliunits per liter (mU/L) | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Tirzepatide Pooled Analysis | Participants of 10 mg and 15 mg tirzepatide arms were pooled in this arm. | | OG001 | Placebo | Participants received matching placebo SC QW. |
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